Colombia
This case study on Colombia was carried out by Luis Mariano Genovesi, UNCTAD Consultant and Law Professor at Universidad de Buenos Aires, Argentina. Mr Genovesi and Maximiliano Chab, ICTSD Regionalism Programme Officer, collected input for the study during a field mission to Bogotá and Cali, Colombia from 25 to 29 January 2010. The case study report was finalized by Kiyoshi Adachi and Christoph Spennemann of the Intellectual Property Unit, under the overall responsibility of Mr James Zhan, Director of the Division on Investment and Enterprise, and Mrs Nazha Benabbes Taarji, Officer-in-Charge, Investment Capacity-Building Branch.
Abbreviations 89 1. Background and methodology 90 2. Description of the firm, structure and range of products 91
2.1 Colombian market 91
2.2 Presence in overseas markets 94
3. Tecnoquímicas’s technological capacity 95
3.1 Know-how conveyed by Tecnoquímicas’s licensors 95
3.2 In-house research and development 96
3.3 Transfer of technology by suppliers and contractors 97
3.4 Skilled workers and professionals 98
3.5 Developments in the biotechnological area 99
3.6 Partnerships with universities and research centres 99
4. The pharmaceutical market in Colombia 100 5. The framework for local production and technology transfer in Colombia 108
5.1 The health security system 108
5.2 Drug regulation 110
5.3 Marketing authorization 110
5.4 Data exclusivity 111
5.5 Clinical trials 112
5.6 Price controls 112
5.7 Patents 113
5.8 Transfer of technology 114
5.9 Foreign direct investment 115
5.10 Industrial policies 116
5.11 Science and technology policies 117
6. Analysis of Tecnoquímicas 119 7. Implications of local production and technology transfer on access
to medicines 122 8. Policy-relevant findings 123 References 127 Annex I: Interviewed individuals and institutions 129 Annex II: Generics manufactured by Tecnoquímicas 130 Annex III: Branded generics manufactured or distributed by Tecnoquímicas 133
Contents
Abbreviations
ANDI Cámara Farmacéutica de la Asociación Nacional de Empresarios de Colombia
ASINFAR Asociación de Industrias Farmacéuticas Colombianas BK+ Bacillus Koch positive
CECIF Centro de la Ciencia y la Investigación Farmacéutica (Centre for Science and Pharmaceutical Research)
CIDEIM
Centro Internacional de Entrenamiento e Investigaciones Médicas (International Medical Research and Training Centre)
CIDEPRO
Centro de Investigación para el Desarrollo de Productos contra Enfermedades Tropicales (Research Centre for the Development of Products to Fight Tropical Diseases)
CNPM Comisión Nacional de Precios de los Medicamentos (National Commission of Drug Price Surveillance)
Colciencias
Departamento Administrativo de Ciencia, Tecnología e Innovación (Administrative Department of Science, Technology and Innovation)
CONPES Consejo Nacional de Política Económica y Social (National Board of Economic and Social Policy)
CSC Colombia Sales Company
DANE Departamento Administrativo Nacional de Estadística DNP Departamento Nacional de Planeación
EPSS Entidades Promotoras de Salud Subsidiada
FOSYGA Fondo de Solidaridad y Garantía del Sistema General de Seguridad Social en Salud
ICESI Universidad ICESI
IFARMA Fundación Instituto para la Investigación del Medicamento en los Sistemas de Salud
INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
MSD Merck, Sharp and Dohme Corporation
POS Plan Obligatorio de Salud (Mandatory Health Care Plan) rEGF recombinant epidermal growth factor
RICYT Red Iberoamericana de Indicadores de Ciencia y Tecnología SGSSS Sistema General de Seguridad Social en Salud (General
System of Social Security in Health)
SNCTeI Sistema Nacional de Ciencia, Tecnología e Innovación (National System of Science, Technology and Innovation)
1. Background and methodology
This case study was designed to investigate the trends in transfer of technology in the pharmaceutical field in Colombia, the source of their technology, the factors behind their sustainability, and the issues that local and multinational companies currently face. Specifically, this case study examines the technological innovation strategy of the largest Colombian pharmaceutical company through its research and development (R&D) efforts; the evolution of transfer of technology from multinational R&D-based firms in the past 20 years; the role that active pharmaceutical ingredients (APIs) and equipment suppliers play in transfer of technology, as well as other means for this purpose such as hiring of professionals or skilled technicians; and the place that universities and R&D institutions have in the transfer of technology in a developing country.
UNCTAD thanks Tecnoquímicas S.A. (Tecnoquímicas) for agreeing to be the subject firm for this case study.
A case study research methodology was used in this study. Data were collected from academic literature and policy documents and through open-ended, face-to-face interviews with individuals in Colombia. Interviewees were identified through purposive sampling. During the fact-finding mission to Bogotá and Cali, Colombia from 25 to 29 January 2010, 18 people from various sectors of the pharmaceutical industry were interviewed, including 9 pharmaceutical experts (affiliated with Laboratorio Franco Colombiano S.A. (Lafrancol), Tecnoquímicas, Asociación de Industrias Farmacéuticas Colombianas (Association of Colombian Pharmaceutical Industries; ASINFAR), Cámara Farmacéutica de la Asociación Nacional de Empresarios de Colombia (Pharmaceutical Chamber, National Business Association of Colombia;
ANDI), and TopPharma Consulting); 7 government representatives (from Departamento Administrativo de Ciencia, Tecnología e Innovación (Colciencias) (Administrative Department of Sciences, Technology and Innovation), Fideicomiso de Promoción de Exportaciones Proexport Colombia (Proexport) (Export Promotion Trust Proexport Colombia), and Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute for Medicines and Food Surveillance; (INVIMA)); and 2 representatives of Fundación Instituto para la Investigación del Medicamento en los Sistemas de Salud (Institute for Research in Medicines and Health Systems Foundation; IFARMA), a nongovernmental organization (NGO).1 Furthermore, four representatives from three different innovative multinational pharmaceutical companies were interviewed during the field mission, which included a visit to a plant operated by one of these companies; however, these multinational laboratories did not authorize their Colombian branches to participate in the case study, so these four representatives agreed to be interviewed off the record.2
1 See Annex I.
2 Their views are accordingly unattributed in this study.
In addition, a semi-structured questionnaire designed to capture the dynamics of firm-level activities related to production and technology transfer was administered to the above-listed firms, the results of which are included in the case study where relevant.3
This case study defines innovation as any new product, process or organizational change that is new to the enterprise, context and country in question. This need not be novel to the world at large. In keeping with the scope of the project, technology transfer was defined as all components of technology, both codified (such as blueprints, hardware, machine parts and plant technologies) and tacit (such as know-how and skills), that are essential to enhance the capacity of the organizations in the recipient country to produce pharmaceutical products.4
2. Description of the firm, structure and range of products
Tecnoquímicas is a Colombian laboratory, located in Cali. It was founded in 1934. Two brothers (Francisco José Barberi and Juan Manuel Barberi) control, in an equal share, 90% of this laboratory through holding companies. The remaining 10% belongs to the International Finance Corporation (IFC), which is part of the World Bank Group. IFC purchased its participation in TECNOQUÍMICAS with a US$ 25 million investment in 2008.
Tecnoquímicas manufactures pharmaceutical drugs, baby care products, personal care products, and animal and veterinary health products. This is done either directly or through companies controlled by Tecnoquímicas.
The most noteworthy of these companies are Adhesivos Internacionales S.A.
(which manufactures adhesive bandages under the CureBand trademark), Tecnosur (which manufactures disposable nappies/diapers) and Indugráficas (which manufactures packaging materials).
2.1 Colombian market
Tecnoquímicas is the largest pharmaceutical laboratory in the Colombian market in terms of value of sales, among both domestic and foreign laboratories, with sales of US$ 361 million in 2009 (La Nota Económica, 2010). The company is also among the bigger firms in the Colombian economy, ranking sixtieth on the list of the largest manufacturing companies in 2008 (Superintendencia de Sociedades, 2002–2008).
Tecnoquímicas’s main strength is in the over-the-counter (OTC) market, but it also ranks fifth in the prescription drugs market. Tecnoquímicas sells generic products under the McKesson (MK) trademark. It also sells branded generics, of both its own trademarks and of trademarks licensed from third parties.
3 See Annex: Field questionnaire.
4 A uniform definition of technology transfer was used for all components of the project, including the trends survey, the regional dialogues and the stakeholder analysis.
Figure 1 shows a package of an MK generic product. Annex II to this case study shows a list of MK generic products and the corresponding therapeutic groups and APIs.